Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis

NCT04714411 | Completed

• 1 other identifier: 014.PHA.2020.A
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

This will be a prospective, open-label, two-center study to assess the safety of omadacycline use in the treatment of hospitalized subjects with moderate to severe DFI with or without Acute osteomyelitis (AOM) who are at a high risk for development of CDI, AKI, and/or resistant pathogens compared to retrospective controls. Prospective enrollment will be continued until the sample size is achieved up to one year from start date (October 2020). Secondary to slower than anticipated enrollment due to the COVID-19 pandemic and initial exclusion of AOM, following protocol amendment, patient enrollment will be continued until the sample size is achieved up to 18 months from amendment approval (anticipate April 2022 - October 2023). A historical matched case cohort (standard of care) at the two hospitals based on ICD10 codes associated with DFI \[E11.(621, 622), E10.(621, 622); L97.(509, 521, 522, 523, 524, 529)\], including subjects with AOM \[M86.(08-09, 10, 16-19, 8X0, 8X7-8X9, 9) will be utilized for comparison.

Conditions

Diabetic Foot Infection

Outcome Measures

Primary Outcomes (2)

• AKI based on RIFLE criteria

  Risk, injury, failure, loss and ESRD

  Sept 2020 - Aug 2021

• Clostridioides difficile Infection

  Frequency of Clostridioides difficile Infections while taking Omadacycline compared to other antibiotics

  Sept 2020 - Aug 2021

Study Arms (2)

Retrospective Cohort

A historical matched case cohort

Prospective Cohort

Subjects will be screened daily via review of the EMR reports of inpatient admissions. Those receiving antibiotics with a notated source of skin/soft tissue infection or OM will be further reviewed to determine if the source of infection is a DFI with or without suspected or confirmed Acute osteomyelitis.

Drug: Omadacycline

Interventions

Omadacycline DRUG

Omadacycline monotgherapy

Prospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult diabetic with DFI hospitalized, 18 years or older, diagnosed with type 1 or 2 diabetes, and have DFI with or without AOM

You may qualify if:

• Acute infection or worsening without systemic antimicrobials within the previous 14 days
• At least one full or partial thickness-infected ulcer at or below the ankle AND
• Purulent drainage OR
• Two of the following:
• Erythema
• Local edema
• Fluctuance
• Induration
• Increased local warmth
• Fever
• No systemic antimicrobials with current hospital admission for more than 48 hours prior to enrollment
• Empiric coverage based on organisms suspected to be caused by susceptible bacteria, if no culture identifies a specific organism; or
• Confirmed susceptibility to omadacycline against any organism identified. Any subject in which a pathogen resistant to omadacycline is identified will be excluded from the study and antibiotics will be changed based on physician discretion.
• Imaging (X-ray or MRI) confirmation of acute osteomyelitis
• Pathology (bone biopsy/culture)

You may not qualify if:

• Age less than 18 years
• Pregnant women
• Chronic osteomyelitis
• Osteomyelitis of the same site previously treated with antibiotics
• Documented presence of osteomyelitis more than 2 weeks prior to index admission
• Necrotic or dead bone identified by pathology
• Unclear chronicity of infection (if unable to determine acute osteomyelitis)
• Has any gangrenous ulcers or necrotizing fasciitis
• Has a pathogen known to be resistant to omadacycline
• Administration of additional systemic antibiotics in combination with omadacycline, not including topical routes or oral vancomycin/fidaxomicin given their local activity within the GI tract
• Contraindication or hypersensitivity to omadacycline/tetracyclines
• Unwilling or unable to participate in study-related procedures or visits

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (2)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Methodist Charlton Medical Center

Dallas, Texas, 75237, United States

Location

Related Publications (7)

• National Center for Health Statistics (US). Health, United States, 2016: With Chartbook on Long-term Trends in Health. Hyattsville (MD): National Center for Health Statistics (US); 2017 May. Report No.: 2017-1232. Available from http://www.ncbi.nlm.nih.gov/books/NBK453378/

  PMID: 28910066 BACKGROUND

• Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.

  PMID: 15111519 BACKGROUND

• Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005 Jan 12;293(2):217-28. doi: 10.1001/jama.293.2.217.

  PMID: 15644549 BACKGROUND

• Prompers L, Huijberts M, Apelqvist J, Jude E, Piaggesi A, Bakker K, Edmonds M, Holstein P, Jirkovska A, Mauricio D, Tennvall GR, Reike H, Spraul M, Uccioli L, Urbancic V, Van Acker K, Van Baal J, Van Merode F, Schaper N. Optimal organization of health care in diabetic foot disease: introduction to the Eurodiale study. Int J Low Extrem Wounds. 2007 Mar;6(1):11-7. doi: 10.1177/1534734606297245.

  PMID: 17344196 BACKGROUND

• Lazaro Martinez JL, Garcia Alvarez Y, Tardaguila-Garcia A, Garcia Morales E. Optimal management of diabetic foot osteomyelitis: challenges and solutions. Diabetes Metab Syndr Obes. 2019 Jun 21;12:947-959. doi: 10.2147/DMSO.S181198. eCollection 2019.

  PMID: 31417295 BACKGROUND

• Johnson MJ, Shumway N, Bivins M, Bessesen MT. Outcomes of Limb-Sparing Surgery for Osteomyelitis in the Diabetic Foot: Importance of the Histopathologic Margin. Open Forum Infect Dis. 2019 Sep 10;6(10):ofz382. doi: 10.1093/ofid/ofz382. eCollection 2019 Oct.

  PMID: 31660346 BACKGROUND

• Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for medicare and private insurers. Diabetes Care. 2014;37(3):651-8. doi: 10.2337/dc13-2176. Epub 2013 Nov 1.

  PMID: 24186882 BACKGROUND

MeSH Terms

Interventions

omadacycline

Study Officials

• Matthew Crotty, PharmD

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 19, 2021
• Study Start: November 5, 2020
• Primary Completion: July 14, 2025
• Study Completion: July 14, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)